Method and apparatus for an orthopedic fixation system

ABSTRACT

An orthopedic fixation system includes a sterile packaged implant kit and a sterile packaged instrument kit. The sterile packaged implant kit includes at least one surgical implant, an insertion device, and an implant package adapted to receive the at least one surgical implant and the insertion device therein. The implant package maintains the at least one surgical implant and the insertion device sterile after sterilization of the sterile packaged implant kit. The sterile packaged instrument kit includes one or more instruments necessary to use the sterile packaged implant kit and an instrument package adapted to receive the one or more instruments therein. The instrument package maintains the one or more instruments sterile after sterilization of the sterile packaged instrument kit.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to an orthopedic fixation systemconsisting of a sterile packaged implant kit and a sterile packagedinstrument kit.

2. Description of the Related Art

Bone fusion and healing in orthopedics often involves metallic implantsbeing attached to bones in some way to fixate them together during thehealing process. There are many forms of bone fixation devices includingintramedullary devices, pins, screws, plates, and staples. Implants madefrom shape memory materials, such as nitinol, are a popular material forfixation because their shape memory and superelastic properties allowthe device to create compression that can augment healing.

Many orthopedic implants are delivered to hospitals in a non-sterileform, and sterilized prior to surgery at the hospital. This is easierfor the medical device manufacturer, since the implant requires lesspreparation than one that is sterile-packaged, however it places an onuson the hospital to insure sterility at the time of surgery. Frequentlythese implants are delivered in caddies, and the implants that are notused in surgery have to be re-sterilized before any subsequent surgicalprocedure.

Many other orthopedic implants are delivered to hospitals in a sterilepackaged form. While this is more difficult and expensive for themedical device manufacturer, it is easier for the hospital to simplyprovide the implant at the time of surgery.

Finally, orthopedic instruments are generally provided as part of aninstrument tray. The tray needs to be sterilized prior to surgical use.Furthermore, after surgery the tray needs to be properly cleaned, andthen subsequently re-sterilized prior to the next use.

While there are numerous combinations of sterile and nonsterileorthopedic implants on the market, they all use an instrument tray thatrequires cleaning and sterilization.

The process of cleaning and sterilization at hospitals is known in theliterature to periodically result in a phenomenon known as HospitalAcquired Infection. In this situation, patients are exposed to aninfectious agent due to improperly cleaned or improperly sterilizedequipment. Preventing and treating these infections is costly tohospitals.

Accordingly, a system is described herein for providing a sterilepackaged implant kit mounted on an insertion device, and a complementarysterile packaged instrument kit. Methods of packaging the system, anddelivering and using the system, are also presented.

SUMMARY OF THE INVENTION

The invention herein consists of a sterile packaged implant kit and acomplementary sterile packaged instrument kit and methods fur use andpackaging thereof.

The sterile packaged implant kit includes an implant mounted on aninsertion device and a drill guide. The sterile packaged implant kitfurther includes an implant tray shaped to hold the at least onesurgical implant, the insertion device, and the drill guide therein, animplant outer cover insertable over the implant tray, and an implantseal securable over the implant outer cover. The implant seal enclosesthe implant outer cover such that the implant, the insertion device, andthe drill guide remain sterile within the implant tray and implant outercover after sterilization of the sterile packaged implant kit.

The sterile packaged instrument kit includes a drill bit, locating pins,an instrument handle, and an implant tamp. The sterile packagedinstrument kit includes an instrument tray shaped to hold the drill bit,locating pins, instrument handle, and implant tamp therein, aninstrument outer cover insertable over the instrument tray, and aninstrument seal securable over the instrument outer cover. Theinstrument seal encloses the instrument outer cover such that the drillbit, locating pins, instrument handle, and implant tamp remain sterilewithin the instrument tray and instrument outer cover aftersterilization of the sterile packaged instrument kit.

A method of using an orthopedic fixation system is as follows. A sterilepackaged implant kit is opened to access an implant, insertion device,and drill guide. A sterile packaged instrument kit is opened to access adrill bit and tamp. The drill guide and the drill bit are used to drillholes in bone. The insertion device is used to insert the implant. Theinsertion device is also used to release and activate the implant. Thetamp is used to push the implant flush with bone. The foregoing methodmay also include the use of a sizing wheel to determine the properimplant selection.

A method of packaging an orthopedic fixation system is as follows. Animplant is inserted into an insertion device, and the insertion deviceis inserted into an implant tray. A drill guide is inserted into theimplant tray. The implant tray is enclosed by inserting an implant outercover over the implant tray and securing an implant seal over theimplant outer cover. A drill bit is inserted into an instrument tray. Animplant tamp is inserted into the instrument tray. One or more locatingpins are inserted into the instrument tray. An instrument handle isinserted into the instrument tray. The instrument tray is enclosed byinserting an instrument outer cover over the instrument tray andsecuring an instrument seal over the instrument outer cover. Theenclosed implant tray and the implant, the insertion device, and thedrill guide therein are sterilized. The enclosed instrument tray and thedrill bit, the implant tamp, the one or more locating pins, and theinstrument handle therein are sterilized.

It is an object of the present invention to present the surgeon with animplant ready for implantation, pre-mounted on an insertion device.

It is a further object of the present invention to provide the implantand insertion in a sterile packaged format.

It is still further an object of the present invention to provide allthe instruments needed for use with this implant in sterile packagedformat.

Still other objects, features, and advantages of the present inventionwill become evident to those of ordinary skill in the art in light ofthe following. Also, it should be understood that the scope of thisinvention is intended to be broad, and any combination of any subset ofthe features, elements, or steps described herein is part of theintended scope of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A provides an isometric view of an orthopedic fixation system.

FIG. 1B provides a plan view of an orthopedic fixation system.

FIG. 2A provides an isometric view of an insertion device being used toinsert an implant into bones.

FIG. 2B provides an isometric view of an implant being released from aninsertion stick into bones.

FIG. 3A provides an exploded isometric view of a sterile-packagedimplant kit.

FIG. 3B provides an assembled isometric view of a sterile-packagedimplant kit.

FIG. 4A provides an exploded isometric view of a sterile-packagedinstrument kit.

FIG. 4B provides an assembled isometric view of a sterile-packagedinstrument kit.

FIG. 5A provides an exploded view of a drill guide and an instrumenthandle.

FIG. 5B provides an assembled isometric view of a drill guide system.

FIG. 6 provides an alternative embodiment of an orthopedic fixationsystem that includes a sizing guide.

FIG. 7 provides a plan view of a sizing guide.

FIGS. 8A-8J provide a sequence of images showing the use of anorthopedic fixation system.

FIG. 9 provides a method for using a sterile orthopedic fixation system.

FIG. 10 provides a method for packaging a sterile orthopedic fixationsystem.

FIG. 11 provides a method for using an orthopedic sizing guide to selectthe proper implant.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

As required, detailed embodiments of the present invention are disclosedherein; however, it is to be understood that the disclosed embodimentsare merely exemplary of the invention, which may be embodied in variousforms. It is firth o be understood that the figures are not necessarilyto scale, and some features may be exaggerated to show details ofparticular components or steps.

In this invention, a method and system for a sterile packaged implantand complementary sterile packaged instrument kit are described. Asshown in FIGS. 1A and 1B, an orthopedic fixation system 100 consists ofone or more sterile packaged implant kits 200, 201, and 202, and asterile packaged instrument kit 300. Implant kits 200, 201, and 202 areidentical, except that the implants maybe sized differently as requiredby the physician.

The orthopedic fixation implant is shown in FIG. 2A. The fixationimplant 205 consists of an implant made from a shape-memory orsuperelastic material such as nitinol. implant 205 has two legs, 206 and207, that are designed to swing inward. Implant 205 is mounted ondisposable insertion device 220. The insertion device 220 holds theimplant 205 such that implants legs 206 and 207 are held mechanically ina parallel position for easier insertion into bone. FIG. 2A shows theimplant 205 being inserted into two bones 208 and 209. Insertion device220 can be twisted of implant 205, as shown in FIG. 2B, releasing theimplant to squeeze bones 208 and 709.

The representative sterile packaged implant kit 200 is shown in moredetail in exploded view FIG. 3A and assembly FIG. 3B. Implant kit 200includes the aforementioned implant 205 and insertion device 220.Implant kit 200 also includes a drill guide 230. The purpose of drillguide 230 is to allow a surgeon to drill parallel holes into hone withthe proper separation distance to match implant 205 and parallel legs206 and 207. Drill guide 230 has a universal mating shaft 231 that canbe used to attach to a handle. The entire assembly, consisting ofimplant 205 mounted to insertion device 220 and matching drill guide 230are placed into an implant package 210 suitable to house implant 205,insertion device 220, and matching drill guide 230 and maintain implant205, insertion device 220, and matching drill guide 230 sterile. Inparticular, implant 205, insertion device 220, and matching drill guide230 are placed into an implant tray 240. Implant tray 240 could be madefrom thermoformed. plastic or a similar material, and is shaped to holdand secure insertion device 220 and drill guide 230. While implant tray240 in the preferred embodiment is shaped to hold insertion device 220with implant 205 mounted, one of ordinary skill in the art willrecognize that implant tray 240 could hold insertion device 220 andimplant 205 separately. Implant tray 240 fits into implant outer cover245, which protects all of the contents. Both implant tray 240 andimplant outer cover 245 can be made from transparent plastic so thatimplant 205 is visible from outside. An implant seal 250 secures overand encloses implant outer cover 245 using any suitable means such as aheat and pressure activated adhesive, Implant seal 250 is made from asuitable material for insuring sterility while still allowing airpassage. After sealing the system with implant seal 250, implant kit 200can be sterilized by any common sterilization method such as gas,radiation, or another type. All of the components of implant kit 200 canbe made from disposable materials such as injection molded plastic,metal, or other suitable materials, with the exception of implant 205which is made from a superelastic or shape-memory material. It is anobjective of implant kit 200 to be packaged and then sterilized tosimplify the surgical implantation of implant 205, and then allow all ofthe other components to be discarded after surgery.

Instrument kit 300 is displayed in exploded view FIG. 4A and assemblyFIG. 4B. Instrument kit 300 is sterile-packaged and designed to work inconjunction with one or more implant kits 200, 201, or 202, or anycombination of implant kits. In this embodiment, the instrument kit 300includes multiple instruments needed by the surgeon for the implant kit.Instrument kit 300 consists of a handle 310 that mates with previouslymentioned drill guide 230. Instrument kit 300 also consists of one ormore locating pins 320, drill bit 330, and tamp 340. Locating pins 320are used to fit inside drill guide 230. Drill bit 330 also fits insidedrill guide 230 and can drill a hole in bone. Tamp 340 is used to pressdown on implant 205 to push it flush to bone. The handle 310, one ormore locating pins 320, drill bit 330, and tamp 340 all fit intoinstrument package 305 suitable to house handle 310, one or morelocating pins 320, drill bit 330, and tamp 340 and maintain handle 310,one or more locating pins 320, drill bit 330, and tamp 340 sterile. Inparticular, the handle 310, one or more locating pins 320, drill bit330, and tamp 340 all fit into instrument tray 350. instrument tray 350is made from a thermoformed plastic or similar material that is shapedto conform and hold each instrument; namely, handle 310, one or morelocating pins 320, drill bit 330, and tamp 340. Instrument tray 350 fitsinside instrument outer cover 360. Both instrument tray 350 andinstrument outer cover 360 can be made from transparent plastic so thateach instrument is visible from outside. An instrument seal 370 securesover and encloses instrument outer cover 360 using any suitable meanssuch as a heat and pressure activated adhesive. Instrument seal 370 ismade from a suitable material for insuring sterility while stillallowing air passage. Instrument seal 370 adheres to instrument outertray 360 to allow instruments 310, 320, 330, and 340 to be sterilizedand then maintain sterility. Instrument kit 300 is sterilized by anycommon method of sterilization such as gas or radiation.

FIG. 5A shows handle 310 and drill guide 230 being positioned forassembly. Shaft 235 of drill guide 230 slides into handle 310 to make aconnection. FIG. 5B shows assembled drill guide assembly 390, consistingof handle 310 and drill guide 23.

In a second embodiment, shown in FIG. 6, the orthopedic fixation systemnow includes an additional component. FIG. 6 shows fixation system 500consisting of one or more implant kits 200, 201, and 202, instrument kit300, and sizing guide 400. Implant kits 200, 201, and 202 and instrumentkit 300 functions the same as in the preferred embodiment. Sizing guide400 is shown in more detail in FIG. 7. It is a sterile packaged devicemade from plastic or a similar disposable material, with incrementalprojections on the perimeter. Representative projections 410 and 411 areshown in FIG. 7, however, any number of projections could be situated onthe perimeter. Projections 410 and 411 have a known separation distancecorresponds to the previously described separation distance of legs 206and 207 on implant 205. The measurement 415 between projections 410 and411 is shown on sizing guide 400.

FIGS. 8A-8J show a sequence of images illustrating the use of asterile-packaged orthopedic fixation system. FIG. 9 shows a method forusing a sterile orthopedic fixation system that corresponds to FIGS.8A-8J. FIG. 8A and step 600 of FIG. 9 show sizing guide 400 being usedto determine the proper size of implant needed for bones 208 and 209.FIG. 8B and step 610 of FIG. 9 show drill guide assembly 390 beingcreated from handle 310 and drill guide 230 by inserting shaft 235 intohandle 310. FIG. 8C and step 620 of FIG. 9 show drill guide assembly 390and drill bit 330 being used to drill a hole into bone 209. FIG. 8Dshows locating pin 320 positioned in drill guide assembly 390 andextending into the hole in bone 209. Locating pin 320 secures the drillguide assembly 390 in place while drill bit 330 is used to drill a holein bone 208. FIG. 8E and step 630 of FIG. 9 show drill guide assembly390 with two locating pins 320 securing it to bone. FIG. 8F shows thatthe two locating pins 320 are left in bones 208 and 209. FIG. 8G andstep 640 of FIG. 9 show implant 205 mounted to insertion device 220,being positioned over bones 208 and 209. FIG. 8H and step 650 of FIG. 9show insertion device 220 being twisted off implant 205 to releaseimplant 205 into bones 208 and 209. FIG. 8I and step 660 of FIG. 9 showimplant 205 being pressed flush against bones 208 and 209 by tamp 340.Finally, FIG. 8J shows multiple implants 205 in position on bones 208and 209.

FIG. 10 shows a method for packaging a sterile orthopedic fixationsystem. Step 700 involves inserting the implant into an insertiondevice. In step 710, the insertion device with implant and correspondingdrill guide is placed into a storage tray. In step 720, the componentsof an instrument kit, including drill bit, location pins, tamp, andinstrument handle are placed into an instrument tray. In step 730 bothtrays are sealed with lids. Finally, in step 740 both trays aresterilized via gas, radiation or other sterilization method.

FIG. 11 shows a method for using a sizing guide to determine theappropriate implant size for an orthopedic surgical procedure. Step 800describes exposing bones that require surgery. Step 810 describes usinga sizing tool by rotating it's projections over the bones. Step 820involves selecting the proper implant that best fits the bones.

Although the present invention has been described in terms of theforegoing embodiments, such description has been for exemplary purposesonly and, as will be apparent to those of ordinary skill in the art,many alternatives, equivalents, and variations of varying degrees willfall within the scope of the present invention. That scope, accordingly,is not to be limited in any respect by the foregoing detaileddescription; rather, it is defined only by the claims that follow.

1-21. (canceled)
 22. An orthopedic fixation system, comprising: asterile packaged implant kit, comprising: at least one implant,comprising legs movable between a first position and a second position,wherein movement of the legs from the first position to the secondposition imparts a force to the implant, further wherein movement of thelegs from the second position to the first position releases the forcefrom the implant, an insertion device adapted for loading with the atleast one implant, wherein the insertion device loaded with the at leastone implant maintains the legs in their second position such that theimplant stores the force, and an implant package adapted to receivetherein the insertion device loaded with the at least one implant,whereby the implant package maintains the insertion device loaded withthe at least one implant sterile after sterilization of the sterilepackaged implant kit.
 23. The orthopedic fixation system of claim 22,wherein the force store the at least one implant causes compression whenreleased.
 24. The orthopedic fixation system of claim 22, wherein the atleast one surgical implant comprises a staple.
 25. The orthopedicfixation system of claim 24, wherein the staple comprises: asubstantially straight bridge having a first end and a second end; afirst leg extending from the first end; and a second leg extending fromthe second end.
 26. The orthopedic fixation system of claim 25, whereinthe insertion device engages the substantially straight bridge such thata portion of the insertion device abuts interior sections of the firstand second legs thereby maintaining the first and second legs in theirsecond position and storing the force in the staple.
 27. The orthopedicfixation system of claim 24, wherein the staple is made fromshape-memory material.
 28. The orthopedic fixation system of claim 24,wherein the staple is made from superelastic material.
 29. Theorthopedic fixation system of claim 22, wherein the implant packagecomprises: an implant tray shaped therein the insertion device loadedwith the at least one implant; an implant outer cover insertable overthe implant tray; and an implant seal securable over the implant outercover such that the insertion device loaded with the at least oneimplant remains sterile within the implant tray and implant outer coverafter sterilization of the sterile packaged implant kit.
 30. Theorthopedic fixation system of claim 22, wherein there are multiple sizesof implant kits.
 31. The orthopedic fixation system of claim 22, whereinthe sterile packaged implant kit further comprises a drill guide. 32.The orthopedic fixation system of claim 31, wherein the implant packagecomprises: an implant tray shaped to hold therein the insertion deviceloaded with the at least one implant and the drill guide; an implantouter cover insertable over the implant tray; and an implant sealsecurable over the implant outer cover such that the insertion deviceloaded with the at least one implant and the drill guide remain sterilewithin the implant tray and implant outer cover after sterilization ofthe sterile packaged implant kit.
 33. The orthopedic fixation system ofclaim 22, further comprising a sterile packaged sizing device todetermine the appropriate size of surgical implant required for asurgical procedure.
 34. The orthopedic fixation system of claim 33,wherein the sizing device is a sizing wheel.
 35. The orthopedic fixationsystem of claim 34, wherein the sizing wheel includes lengthmeasurements on its circumference.